The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

What Is Corrective Action and Preventive Action (CAPA)?

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Corrective Action Preventive Action (CAPA) is an approach used to investigate and resolve quality issues along with identifying their causes. It was introduced as a result of Food and Drug Administration’s (FDA) requirement under FDA 21 CFR 820.100. The CAPA mainly consists of two functions:

Corrective Action – The goal of Corrective Action is to identify the root cause of the product and quality problems and take appropriate action against them. This includes:

Review and definition of a problem

Identification of the root cause of a problem

Development of action plan for correction and prevention

Implementation of the plan

Evaluation of the plan efficiency

Preventive Action – The goal of Preventive Action is to prevent the problem from recurring in the near future. This includes:

Identification of potential problems

Identification of root cause of the problem

Development of recurrence prevention plan

Implementation of the plan

Review of effectiveness of actions taken for prevention

CAPA and The Procedures

To implement an effective CAPA plan, the following steps must be followed:

Evaluate the seriousness of the problem and how it would impact the business

Evaluate the available procedures for investigation

Analyze the problem with accurate data

Create an action plan that addresses all the problems and solutions to prevent them

Implement the plan

Perform regular follow-ups to ensure the effectiveness of the solutions

A CAPA plan is necessary to ensure problems and non-conformity are reported and prevented in stipulated time. To know more about how to streamline CAPA procedures and other robust quality solutions, reach out to Freyr at sales@freyrsolutions.com.